Smiths Medical Issues Urgent Medical Device Notification Informing Customers of a Potential Issue With Certain Bivona Tracheostomy Tubes
Smiths Medical Issues Urgent Medical Device Notification Informing Customers of a Potential Issue With Certain Bivona Tracheostomy Tubes
For further inquiries, please contact Smiths Medical using the information provided below.MINNEAPOLIS, Aug. 19, 2024 /PRNewswire/ -- Smiths Medical issued an Urgent Medical Device Notification on May 29, 2024, to notify affected customers of a potential issue with certain Bivona Tracheostomy Tubes.
史密斯醫療在2024年5月29日發佈了一份緊急醫療器械通知書，以通知受影響的客戶，某些Bivona氣管切開管存在潛在問題。
All impacted customers and distributors were sent a letter outlining the risk and providing specific steps to determine whether their devices are affected or not and what steps to follow if they have affected product in service. A copy of that letter as well as a list of affected products can be accessed on ICU Medical's website here.
所有受影響的客戶和經銷商都會收到一封信，列出了風險，並提供了具體步驟來判斷他們的器械是否受到影響，以及如果他們使用的產品受到影響應該遵循哪些步驟。信件的副本和受影響產品的清單可在icu醫療的網站上訪問。
The customer notification sent on May 29, 2024, indicated that if the flange on the item is torn or broken, the tracheostomy tube may not stay in position in the trachea. This can lead to tracheostomy displacement or decannulation. Either event may result in an inability to properly ventilate or protect the airway and may contribute to a catastrophic adverse event.
2024年5月29日發送給客戶的通知指出，如果項目上的法蘭裂開或破裂，氣管切開管可能無法在氣管中保持位置。這可能導致氣管切開的移位或拔管。任何一種情況都可能導致無法正確通氣或保護氣道，並可能導致災難性的不良事件的發生。
For further inquiries, please contact Smiths Medical using the information provided below.
如需進一步查詢，請使用以下提供的信息聯繫史密斯醫療。
|
Smiths Medical Contact |
Contact Information |
Areas of Support |
|
Global Complaint Management |
[email protected] 1-(866)-216-8806 |
To report adverse events or |
|
Customer Service |
[email protected] 1-(800)-259-5361 |
Questions about your product |
|
史密斯醫療聯繫人 |
聯繫信息 |
支持領域 |
|
全球投訴管理 |
[email protected] 1-(866)-216-8806 |
報告不良事件或 |
|
客戶服務 |
[email protected] 1-(800)-259-5361 |
有關您的產品的問題和/或更換 |
The U.S. Food and Drug Administration (FDA) has been notified of this action.
使用該產品出現的不良反應或質量問題可通過FDA的MedWatch不良事件報告計劃進行在線、常規郵件或傳真報告。
Adverse reactions or quality problems experienced with this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
在線填寫並提交報告：
- Complete and submit the report Online:
- Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
- 常規郵件或傳真：下載表格或致電1-800-332-1088要求報告表格，然後填寫並退回預先填寫地址表格上的地址，或傳真至1-800-FDA-0178
- 普通郵件或傳真：下載表格或致電1-800-332-1088申請報告表格，然後填寫並寄到預先填寫地址的表格上或傳真至1-800-FDA-0178。
Media Contact:
Harrison Richards
949-366-4261
[email protected]
媒體聯繫人：
哈里森·理查茲
949-366-4261
[email protected]
SOURCE Smiths Medical
資料來源:史密斯醫療
